hydromorphone
Brand names: Dilaudid
Hydromorphone (Dilaudid) is a strong pain medicine. It is used to treat severe pain when other pain medicines do not work well enough.
Drug Shortage Alert
hydromorphone is currently listed as in shortage by the FDA. Affected manufacturer: Fresenius Kabi USA, LLC. Status: Unavailable.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$3.96/unit
Generic Price
$0.29/unit
Generic Savings
93%
Generic Available
Yes (11 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats severe pain that requires an opioid pain medicine.
Common side effects
Lightheadedness, Dizziness, Sleepiness
Key warnings
This medicine has a boxed warning.
How It Works
Hydromorphone works by binding to receptors in the brain and spinal cord. This blocks pain signals from reaching the brain. This results in a decreased feeling of pain.
How to Take It
Take this medicine exactly as your doctor tells you. The oral solution is usually taken every 3 to 6 hours as needed for pain. Tablets are usually taken every 4 to 6 hours as needed for pain. Your doctor will start you on the lowest dose and adjust it as needed.
Pregnancy & Breastfeeding
Using this medicine for a long time during pregnancy can cause withdrawal symptoms in the baby after birth. Talk to your doctor if you are pregnant or plan to become pregnant. This medicine may not be recommended during labor.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store at room temperature (68° to 77°F) and protect from light. Keep this medicine secure and dispose of it properly.
Side Effects (from patient reports)
Based on 149,615 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 90,652 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
90,652
Death-Related Reports
27,836
Hospitalization Reports
16,698
Top Indication
Pain
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG DEPENDENCE | 35,077 |
| 2 | OVERDOSE | 22,994 |
| 3 | PAIN | 22,130 |
| 4 | EMOTIONAL DISTRESS | 17,685 |
| 5 | DEATH | 14,868 |
| 6 | DRUG WITHDRAWAL SYNDROME | 14,321 |
| 7 | TOXICITY TO VARIOUS AGENTS | 10,057 |
| 8 | NAUSEA | 4,622 |
| 9 | DRUG INEFFECTIVE | 4,350 |
| 10 | FATIGUE | 3,506 |
| 11 | VOMITING | 3,373 |
| 12 | ANXIETY | 3,352 |
| 13 | OFF LABEL USE | 3,245 |
| 14 | DRUG ABUSE | 3,103 |
| 15 | HEADACHE | 2,920 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine has a boxed warning. It can cause serious and life-threatening risks. Taking too much can cause overdose and death. It can cause addiction, abuse, and misuse. It can also cause very slow or stopped breathing. Accidental intake, especially by a child, can cause a fatal overdose. Taking with alcohol or other depressants can cause coma and death. If you are pregnant, long-term use can cause withdrawal symptoms in the newborn.
Known Drug Interactions
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Both of these medications can increase the levels of a brain chemical called serotonin, which can lead to a serious reaction.
What to do: Tell your doctor immediately if you feel confused, agitated, or have a very fast heartbeat while taking these together.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Both drugs affect the serotonin system in the brain, and taking them together can cause serotonin levels to become dangerously high.
What to do: Your doctor should monitor you closely for signs of serotonin syndrome, such as confusion, sweating, or a fast heartbeat.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: This muscle relaxant and the pain medicine both impact serotonin levels, which can lead to a rare but serious reaction in the body.
What to do: Watch for symptoms like muscle stiffness or shivering and let your healthcare provider know immediately if they occur.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: These medications both change how serotonin works in your brain, which increases the risk of a severe and potentially dangerous reaction.
What to do: Use this combination with caution and report any unusual changes in your mood or physical coordination to your doctor.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Examples: Phenelzine, tranylcypromine, and linezolid.
Mechanism: This antibiotic acts as an MAO inhibitor, which can cause a dangerous buildup of serotonin when used with certain pain medications.
What to do: Your doctor may need to adjust your treatment or monitor you very carefully for signs of a serotonin reaction.
Common Questions
Can I stop taking this medicine suddenly?
Can I drink alcohol while taking this medicine?
What should I do if I feel like I'm becoming addicted to this medicine?
Can I drive while taking this medicine?
What should I do if I have trouble breathing?
Can I take other medicines with this?
How do I measure the oral solution?
What are the signs of an overdose?
Can this medicine cause constipation?
Is it safe to take this medicine if I have asthma?
What are the common side effects of hydromorphone?
Does hydromorphone interact with other medications?
What drug class is hydromorphone?
Is there a generic version of hydromorphone?
Is hydromorphone safe during pregnancy?
Is hydromorphone currently in shortage?
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What the FDA Data Shows for hydromorphone
The FDA label for hydromorphone (sold under brand names such as Dilaudid) classifies it as a prescription-only medication in the Opioid Analgesic class. This medicine treats severe pain that requires an opioid pain medicine. Official labeling lists 11 commonly reported side effects, including Lightheadedness, Dizziness, Sleepiness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 149,615 voluntary reports. The database also lists 13 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.29 versus $3.96 for the brand — a 93% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 4, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages